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Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

Information source: Materia Medica Holding
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Ergoferon (Drug); Oseltamivir (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Materia Medica Holding

Official(s) and/or principal investigator(s):
Mikhail Putilovskiy, MD, PhD, Study Director, Affiliation: Materia Medica Holding

Summary

The purpose of this study is:

- to assess clinical efficiency of Ergoferon for treatment of influenza

- to assess safety of Ergoferon for treatment of influenza

- to compare efficiency of Ergoferon and Tamiflu for treatment of influenza

Clinical Details

Official title: Multicentre Open Label Comparative Parallel-group Randomized Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Patients With Normal Body Temperature

Secondary outcome:

Percentage of Patients With Resolution of Influenza Symptoms

Time to Resolution of the Influenza

Mean Body Temperature

Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)

The Number of the Antipyretic Intake

Change in the Patient's Quality of Life.

Change in the Subjective Health Status

Percentage of Patients With Complications of the Influenza

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients of both sexes aged from 18 to 60 inclusively. 2. Patients with body temperature >37,8°C at the moment of examination by the doctor; with at least one catarrh symptom (cough, rhinitis, sore throat) and one intoxication symptom (myalgia, fever/hyperhidrosis, malaise, weakness, headache) during seasonal influenza morbidity. 3. Diagnosed influenza confirmed by express diagnostics (presence of antigens of influenza virus in nasal passages epithelium and proved by QuickVue immunological test). 4. The possibility to start therapy within 24 hours after the onset of the first influenza symptoms. 5. Signed Informed Consent form for participation in the study. Exclusion Criteria: 1. Patients aged below 18 years and above 60 years. 2. Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides). 3. Vaccination against influenza prior to epidemic season onset. 4. Medical history of polyvalent allergy. 5. Allergy/ intolerance to any of the components of medications used in the treatment. 6. Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial. 7. Chronic renal insufficiency. 8. Intake of medicines listed in the section "Prohibited concomitant treatment" for 15 days prior to the inclusion in the trial. 9. Pregnancy, breast feeding, unwillingness to keeping to contraception method during the study. 10. Drug addiction, alcohol usage in the amount over 2 units of alcohol per day. 11. Patients, who from investigator's point o view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines. 12. Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial. 13. The patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the reseacher. The immediate relatives includes husband / wife, parents, children, brothers (or sisters), regardless of whether they are natural or adopted. 14. The patient works for OOO "NPF "Materia Medica Holding" (i. e. is the company's employee, temporary contract worker or designated official responsible for carrying out the research) or the immediate relative.

Locations and Contacts

Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation, Moscow 129090, Russian Federation

Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science, Moscow 105064, Russian Federation

State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov" of Ministry of Health and Social Development of Russian Federation, Moscow 117997, Russian Federation

State Budgetary Educational Institution of Higher Professional Education "Smolensk State Medical Academy" of Ministry of Health and Social Development of Russian Federation, Smolensk 214019, Russian Federation

St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106", St. Petersburg 198328, Russian Federation

St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117", St. Petersburg, Russian Federation

State Educational Institution of Higher Professional Education "Voronezh State Academy named after N.N. Burdenko" of Ministry of Health and Social Development of Russian Federation, Voronezh 394036, Russian Federation

State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy" of Ministry of Health and Social Development of Russian Federation, Yaroslavl 150000, Russian Federation

Additional Information

Starting date: February 2011
Last updated: June 1, 2015

Page last updated: August 23, 2015

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